Pertuzumab, trastuzumab, and hyaluronidase-zzxf

What is Pertuzumab, trastuzumab, and hyaluronidase-zzxf?

• Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase is a fixed-dose combination medication used to treat adults with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adults with early HER2-positive breast cancer.

Pertuzumab-HER2 complex 1S78

Trastuzumab-HER2 complex 1N8Z

Hyaluronidase 1 2PE4

What are the uses of this medicine?

Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) is to be given with docetaxel or other chemotherapy to treat:

• Breast cancer that is HER2 positive.

It is used:

• As neoadjuvant therapy (to shrink the tumor before surgery) in adults with locally advanced, inflammatory, or early-stage breast cancer. It is given with chemotherapy.
• As adjuvant therapy in adults with early-stage breast cancer who have a high risk that their cancer will recur (come back). It is given with chemotherapy.
• In adults with metastatic breast cancer that has not been treated with anti-HER2 therapy or chemotherapy. It is given with docetaxel.
• It can be given in less time than pertuzumab or trastuzumab, which are given as infusions.

How does this medicine work?

Pertuzumab:

• Pertuzumab (per tooz’ ue mab) is humanized monoclonal antibody to HER2 which is a growth factor receptor that is overexpressed in 20% to 25% of breast cancers.
• The interaction of epidermal growth factor (EGF) with HER2 results in rapid cell growth and proliferation via intracellular pathways that include MAP and PI3 kinase.
• Blockage of this pathway results in cell cycle arrest and cell death.
• Pertuzumab binds to the dimerization site on the HER2 receptor and prevents pairing of receptors and blocks their intracellular signaling.
• Because the binding site for pertuzumab is different from that of trastuzumab (another monoclonal antibody to HER2), they can be used together and are believed to have additive antitumor effects.

Trastuzumab:

• Trastuzumab (tras tooz’ ue mab) is humanized monoclonal antibody to HER2 which is a human growth factor receptor that is overexpressed in 20% to 25% of breast cancers.
• The interaction of epidermal growth factor (EGF) with HER2 results in rapid cell growth and proliferation via intracellular pathways that include MAP and PI3 kinase.
• Binding of trastuzumab to the HER2 receptor blocks this cell signaling pathway and causes growth arrest.
• Trastuzumab was shown to decrease recurrences and prolong survival in women with breast cancer that were HER2 positive.

Hyaluronidase:

• Hyaluronidase is made in the laboratory and given with other drugs by injection under the skin to treat certain conditions.
• Using hyaluronidase to break down hyaluronic acid helps make the fluids and connective tissue thinner so the drugs can move more easily into the tissues.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase, or to any of its excipients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Tell your doctor and pharmacist if you are being treated with anthracycline medications for cancer such as daunorubicin (Cerubidine), doxorubicin (Doxil), epirubicin (Ellence), and idarubicin (Idamycin) at this time or within 7 months after receiving pertuzumab, trastuzumab, and hyaluronidase-zzxf injection.

Is this medicine FDA approved?

• The fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase was approved for medical use in the United States in June 2020.

How should this medicine be used?

• Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency.

Recommended dosage:

• The initial dose of Phesgo is 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase administered subcutaneously over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase administered subcutaneously over approximately 5 minutes.

Neoadjuvant Treatment of Breast Cancer:

• Administer Phesgo by subcutaneous injection every 3 weeks and chemotherapy by intravenous infusion preoperatively for 3 to 6 cycles.

Adjuvant Treatment of Breast Cancer:

• Administer Phesgo by subcutaneous injection every 3 weeks and chemotherapy by intravenous infusion postoperatively for a total of 1 year (up to 18 cycles).

Metastatic Breast Cancer (MBC):

• Administer Phesgo by subcutaneous injection and docetaxel by intravenous infusion every 3 weeks.

Administration:

• Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection comes as a liquid to be injected subcutaneously (under the skin).
• Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection is given by a doctor or nurse in a hospital or medical facility.
• It is usually given into the thigh over 5 to 8 minutes once every 3 weeks.
• The length of your treatment will depend on the condition that you have and how well your body responds to treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase/15 mL (80 mg, 40 mg, and 2,000 units/mL) of solution in a single-dose vial.
• 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase/10 mL (60 mg, 60 mg, and 2,000 units/mL) of solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Phesgo

What side effects can this medication cause?

The most common side effects of this medicine include: In Neoadjuvant and Adjuvant Treatment of Breast Cancer:

• alopecia, nausea, diarrhea, anemia, and asthenia

In Metastatic Breast Cancer:

• diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy

What special precautions should I follow?

• Phesgo can cause hypertension, arrhythmias, left ventricular cardiac dysfunction, disabling cardiac failure, cardiomyopathy, and cardiac death. Prior to initiation of Phesgo, conduct a thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
• Phesgo can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of Phesgo. Advise pregnant women and females of reproductive potential that exposure to Phesgo during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Phesgo.
• Phesgo can cause serious and fatal pulmonary toxicity. Discontinue Phesgo for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Monitor patients until symptoms completely resolve.
• Phesgo may exacerbate chemotherapy-induced neutropenia.
• Severe administration-related reactions (ARRs), including hypersensitivity, anaphylaxis, and events with fatal outcomes, have been associated with intravenous pertuzumab and trastuzumab. Permanently discontinue with Phesgo in patients who experience anaphylaxis or severe injection-related reactions. Phesgo is contraindicated in patients with known hypersensitivity to pertuzumab, trastuzumab, hyaluronidase or to any of its excipients.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Phesgo can cause fetal harm when administered to a pregnant woman.
• Phesgo is administered during pregnancy, or if a patient becomes pregnant while receiving Phesgo or within 7 months following the last dose of Phesgo, health care providers and patients should immediately report Phesgo exposure to Genentech at 1-888-835-2555.

Can this medicine be used in children?

• The safety and effectiveness of Phesgo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PERTUZUMAB
• TRASTUZUMAB
• HYALURONIDASE (HUMAN RECOMBINANT)

Inactive ingredients:

• HISTIDINE
• HISTIDINE MONOHYDROCHLORIDE
• TREHALOSE DIHYDRATE
• SUCROSE
• POLYSORBATE 20
• METHIONINE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Genentech, Inc.
• A Member of the Roche Group
• 1 DNA Way
• South San Francisco, CA

What should I know about storage and disposal of this medication?

• Store Phesgo vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Do not shake.

• Dailymed label info on Pertuzumab, trastuzumab, and hyaluronidase-zzxf
• FDA Pertuzumab, trastuzumab, and hyaluronidase-zzxf

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